US FDA Patient Decision Checklist for Breast Implants: Results of a Survey to Members of The Aesthetic Society, April 2022.

Abstract

The US Food and Drug Administration (FDA), in response to concerns that patients undergoing breast implant surgery were not adequately informed about the risks of receiving an implanted medical device, mandated a Patient Decision Checklist (PDC) in October 2021. Breast implant manufactures communicated with plastic surgeons in 2022 regarding the use of the PDC as a condition for the sale of breast implants. Plastic surgeons voiced concerns over the accuracy of the content in the PDC and its confusing statements about the risk of adverse events associated with breast surgery. In April 2022, The Aesthetic Society developed a survey that was sent to its members regarding their experiences with the PDC. This was a 5-question survey, with 1 additional place for comments. The purpose of this survey was to develop data based on the 6-month experience of plastic surgeons with the PDC. A total of 206 Aesthetic Society members (9%) participated in the survey (1849 total active members in the United States). Patients deserve appropriate information prior to breast implant surgery to make an informed decision after reviewing the potential risks and benefits. The authors believe that there is still more work to be done to create an ideal PDC that is fair and balanced, scientifically describes risk incidence in a way that patients understand, and can be updated.